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Middle School Matters Study (MSM)

Primary Purpose

Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Positive Thoughts and Actions Program
Individual Support Program
Sponsored by
Seattle Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Depression focused on measuring Depressive Symptoms, Depression prevention, Adolescents, School-Based Services, Health Behavior

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 7th and 8th grade students at 4 participating middle schools
  • Score 14 or above on the Mood and Feelings Questionnaire at screening (approximately top 25%)
  • No imminent plans to move or change to non-participating school
  • At minimum 6th grade language skills
  • Agree to participate in random assignment and research interviews
  • One Parent/caregiver willing to complete research interviews

Exclusion Criteria:

  • Student with past or current Major Depressive Disorder (MDD) or Probable MDD
  • Students with parents who do not speak English or Spanish
  • Students in concurrent treatment
  • Students in self-contained classroom, or with cognitive delays, or emotional behavioral problems that would preclude them from benefiting from the group or being a good group member
  • Parent not willing to complete research interviews

Sites / Locations

  • Seattle Children's

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Skill Group Program

Individual Support Program

Arm Description

Positive Thoughts and Actions Program

Measure of Adolescent Potential for Suicide (MAPS) - modified

Outcomes

Primary Outcome Measures

Moods and Feelings Questionnaire (MFQ; child and parent version)
Depressive symptoms of the child are assessed on the MFQ. Youth completed the MFQ at all 4 timepoints, parent ratings of students symptoms were collected at baseline, post-intervention, and 12 month follow up.

Secondary Outcome Measures

Parent-Child Communication (PCC; child and parent version)
Parent child communication were assessed using the child and parent version of the PCC. Children completed the PCC at all 4 timepoints, parent ratings were collected at baseline, post-intervention, and 12 month follow up.
Behavioral Assessment System for Children-2nd Edition (BASC-2; student, parent, & teacher version)
The adolescent version of the Teacher Rating Scale, Parent Rating Scale, and the Student Self-Report of Personality of the BASC-2 were used to assess school functioning and social functioning.
Health Enhancing Behavior Index (HEBI)
Health behaviors (diet, exercise, and sleep) are self-reported by the youth on the HEBI.
Service Use Interview (Service for Children and Adolescence Parent Interview-modified)
The service use interview was used to measure treatment history and services received during the course of the intervention and follow up.
Schedule for Affective Disorders and Schizophrenia for School-Age Children (KSADS)
The depression module of the KSADS was used to assess DSM-IV symptoms of major depression and depressive disorder at the 12-month follow up.

Full Information

First Posted
October 5, 2010
Last Updated
February 13, 2014
Sponsor
Seattle Children's Hospital
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT01220635
Brief Title
Middle School Matters Study
Acronym
MSM
Official Title
Prevention of Depression Within Salient Adolescent Contexts
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seattle Children's Hospital
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study aims to evaluate the short-term and long-term efficacy of two preventative intervention approaches designed to support middle school youth.
Detailed Description
This study involve two parts: Part 1 entailed screening 7th and 8th graders from 4 public middle schools to identify students who may be showing moderate signs of stress. Students who score at the designated cutoff on a depression symptoms measure received a brief check-in to determine eligibility for the follow up randomized trial (Part 2). An "indicated" sample of 120 adolescents in the 7th and 8th grade and their caregivers were randomly assigned to a brief, Individual Support Program (ISP) comparison group or a Skills Group Program. Research interviews were conducted at multiple timepoints with students and caregivers, and teacher questionnaires were used to examine changes in outcome measures. Following completion of the intervention, all participants were followed for 12-months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Depressive Symptoms, Depression prevention, Adolescents, School-Based Services, Health Behavior

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Skill Group Program
Arm Type
Experimental
Arm Description
Positive Thoughts and Actions Program
Arm Title
Individual Support Program
Arm Type
Active Comparator
Arm Description
Measure of Adolescent Potential for Suicide (MAPS) - modified
Intervention Type
Behavioral
Intervention Name(s)
Positive Thoughts and Actions Program
Intervention Description
Students in the skills group will attend a 12-session (50 minutes each), 12-week program with 4-6 other students. The skills group will take place at school during school hours. Parents in the skill group will be asked to participate in two parent group workshops to take place at their child's school or other participating middle school (2-hours each). In addition, the skill group leader will conduct two individual family meetings with the student and parent(50 minutes each).
Intervention Type
Behavioral
Intervention Name(s)
Individual Support Program
Intervention Description
Students will be individually interviewed (60-90 minutes) at school to review areas of stress and support. The health professional conducting the interview will reinforce the student's strengths, and provide connections to sources of help from caring adults at home and at school. Parents will be called following the assessment to help the family locate appropriate resources if needed (e.g., tutoring resources, school counselor).
Primary Outcome Measure Information:
Title
Moods and Feelings Questionnaire (MFQ; child and parent version)
Description
Depressive symptoms of the child are assessed on the MFQ. Youth completed the MFQ at all 4 timepoints, parent ratings of students symptoms were collected at baseline, post-intervention, and 12 month follow up.
Time Frame
up to 1 year
Secondary Outcome Measure Information:
Title
Parent-Child Communication (PCC; child and parent version)
Description
Parent child communication were assessed using the child and parent version of the PCC. Children completed the PCC at all 4 timepoints, parent ratings were collected at baseline, post-intervention, and 12 month follow up.
Time Frame
up to 1 year
Title
Behavioral Assessment System for Children-2nd Edition (BASC-2; student, parent, & teacher version)
Description
The adolescent version of the Teacher Rating Scale, Parent Rating Scale, and the Student Self-Report of Personality of the BASC-2 were used to assess school functioning and social functioning.
Time Frame
up to 1 year
Title
Health Enhancing Behavior Index (HEBI)
Description
Health behaviors (diet, exercise, and sleep) are self-reported by the youth on the HEBI.
Time Frame
up to 1 year
Title
Service Use Interview (Service for Children and Adolescence Parent Interview-modified)
Description
The service use interview was used to measure treatment history and services received during the course of the intervention and follow up.
Time Frame
up to 1 year
Title
Schedule for Affective Disorders and Schizophrenia for School-Age Children (KSADS)
Description
The depression module of the KSADS was used to assess DSM-IV symptoms of major depression and depressive disorder at the 12-month follow up.
Time Frame
up to 1 year

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 7th and 8th grade students at 4 participating middle schools Score 14 or above on the Mood and Feelings Questionnaire at screening (approximately top 25%) No imminent plans to move or change to non-participating school At minimum 6th grade language skills Agree to participate in random assignment and research interviews One Parent/caregiver willing to complete research interviews Exclusion Criteria: Student with past or current Major Depressive Disorder (MDD) or Probable MDD Students with parents who do not speak English or Spanish Students in concurrent treatment Students in self-contained classroom, or with cognitive delays, or emotional behavioral problems that would preclude them from benefiting from the group or being a good group member Parent not willing to complete research interviews
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carolyn A McCarty, Ph.D.
Organizational Affiliation
Seattle Children's Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seattle Children's
City
Seattle
State/Province
Washington
ZIP/Postal Code
98115
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27795599
Citation
Duong MT, Kelly BM, Haaland WL, Matsumiya B, Huey SJ Jr, McCarty CA. Mediators and Moderators of a School-Based Cognitive-Behavioral Depression Prevention Program. Cognit Ther Res. 2016 Oct;40(5):705-716. doi: 10.1007/s10608-016-9780-2. Epub 2016 Apr 28.
Results Reference
derived

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Middle School Matters Study

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